Otsuka ICU Medical LLC is voluntarily recalling one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level nationwide due to a potential product mix-up, the US Food and Drug Administration said.
The affected lot (NDC: 0990-7984-23, Lot 1042188) may contain an overwrap labeled as 0.9% SODIUM CHLORIDE Injection, USP, while the actual product inside may be POTASSIUM CHLORIDE Inj. 10 mEq (NDC 0990-7074-26, Lot 1035181). The issue was identified through a customer complaint after a 10 mEq Highly Concentrated POTASSIUM CHLORIDE Injection 100 mL bag was found inside an overwrap of 0.9% SODIUM CHLORIDE Injection, USP 100 mL.
In its risk statement, the company said there is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes. Populations most at risk include premature infants, patients on chronic parenteral nutrition, patients with a history of cardiac arrhythmias, patients with chronic renal insufficiency, patients who have acute renal failure, and patients on potassium-sparing diuretics.
For those groups, the company said there is a reasonable probability of adverse events such as neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest.
To date, Otsuka ICU Medical LLC has not received any reports of adverse events related to this recall.